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Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

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ClinicalTrials.gov Identifier: NCT01228461
Recruitment Status : Completed
First Posted : October 26, 2010
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
Vanderbilt University Medical Center ( Vanderbilt University )

Brief Summary:

Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications such work has for effective interventions, little is known about the underlying pathophysiology of fatigue, association with medical co-morbidities and factors that may help predict those to be at highest risk.

The proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship Program together with the investigators Hematologic Malignancies Program. In adolescent and young adults (AYA), ages 18 - 39 the investigators will address the following:

Primary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for fatigue

Secondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine activity and fatigue Aim 2: Evaluate the association between fatigue and self reported fatigue in AYA Hodgkin lymphoma (HL) survivors.


  1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to general population and will be associated with impaired functional outcome.
  2. Risk factors for fatigue include higher disease stage, B symptoms and elevated erythrocyte sedimentation rate at diagnosis, dose density of chemotherapy and higher doses and more expanded fields of radiotherapy.
  3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine complications.
  4. Levels of specified proinflammatory cytokines are associated with increased fatigue.

Condition or disease
Fatigue Hodgkin Lymphoma

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : February 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

AYA with Fatigue and Hodgkin Lymphoma

Primary Outcome Measures :
  1. Prevalence and severity of fatigue and its impact on functional outcomes [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evaluate the association between levels of proinflammatory cytokine activity and fatigue [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Serum samples for IL-1ra and CRP

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescents and young adult survivors of Hodgkin Lymphoma

Inclusion Criteria:

  • Currently 18 years of age or older
  • Alive without evidence of recurrent disease
  • Must be off therapy (not on active treatment for HL or other malignancies)
  • Must not be on any form of chemotherapy (oral or intravenous [IV])
  • Provide informed consent
  • Can read and understand English
  • Treated with risk-adapted therapy which may include radiotherapy doses < 30 Gy

Exclusion Criteria:

  • Evidence of a subsequent malignancy following lymphoma treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228461

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University

Responsible Party: Vanderbilt University
ClinicalTrials.gov Identifier: NCT01228461     History of Changes
Other Study ID Numbers: 091550
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Vanderbilt University Medical Center ( Vanderbilt University ):
Hodgkin Lymphoma Survivors
Adolescent and Young Adults

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms